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Quality Assurance

The SSD is required to use a quality management system (QMS) which demonstrates to their customers the capability to control the processes that determine the acceptability of product supplied.

The Quality System employed by the SSD is aimed at preventing and detecting any non-conformity during production and implementing the means to prevent its recurrence.

The Sterile Services Department has registered firm status to the QMS of "BS EN ISO 13485 2003 Medical devices - Quality management systems - Requirements for regulatory purposes" and is independently audited twice a year to maintain this status.

The Sterile Services Manager and each member of the SSD staff is responsible for ensuring that the part of the activities which they control is effectively operated in accordance with a Quality Manual, associated Quality Control Procedures and work instructions which are required by The Quality Management System.

The Quality Manual defines how every member of staff contributes to the achievement of the Quality Policy and relies on all staff to continually monitor the activities being undertaken.

The Quality Control Procedures are the written procedures of key production and quality areas chosen for planned auditing to maintain work quality levels and detect any areas of non-conformance to work instructions.

Work Instructions are the detailed instructions of every aspect of the production cycle.